April 8, 2014

ISAPP filed comments with the FDA on its guidance, which requires that essentially all human research to evaluate functional effects of foods be conducted under an IND. ISAPP requested that FDA revise the current guidance to remove their requirement for INDs for human research conducted on foods and that the guidance make it clear that prebiotics and probiotics have lawful, recognized food uses, which should be able to be researched in the USA without an IND.

Comments by the law firm, Hyman, Phelps & McNamara, also are of interest.